CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)

NCT07254962 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MP-37-2026-12048
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects areas such as the mouth, throat, and voice box. Despite medical progress, little has changed in the care for patients with HPV-negative cancer. The standard care involves surgery followed by radiation or chemotherapy if needed. However, delays in starting treatment - especially beyond six weeks - are linked to worse outcomes. Many patients also experience cancer returning within two years, often making it harder to treat. This study aims to improve outcomes by giving patients a short course of capecitabine, a chemotherapy pill, before surgery. Capecitabine is easier to tolerate than traditional intravenous chemotherapy and has shown promising results in shrinking tumors. Researchers believe that starting this oral treatment early could reduce delays, shrink tumors, make surgery less complex, and improve survival. The clinical trial will randomly assign patients with newly diagnosed stage III or IVa HPV-negative head and neck cancer to receive either standard care or capecitabine before surgery. Surgery will be performed within six weeks of diagnosis, followed by additional therapy as needed. The study will measure how well the tumor responds under the microscope after surgery, how much it shrinks on scans, the safety of the treatment, and cancer-free survival at two years. It will also explore biological markers linked to treatment response. If successful, this approach could offer a simpler, faster, and more effective way to treat head and neck cancer, leading to earlier treatment, less invasive surgery, and improved patient outcomes. The study plans to include about 62 patients to evaluate the benefits of this new treatment strategy

Conditions

Head Neck Cancer; Mouth Cancer; Throat Cancer; Larynx Cancer; Skin Cancer Face

Keywords

window of opportunity; surgery; neoadjuvant; capecitabine; Head and neck cancer; HPV-negative

Outcome Measures

Primary Outcomes (1)

• Pathologic response

  modified Ryan criteria: score based on the following: no viable cancer, rare groups of cancer cells, residual cancer with tumor regression, no evident tumor regression

  From initiation of capecitabine to surgery

Secondary Outcomes (1)

• Treatment toxicity (grade 3 or greater)

  Within first 60 days of treatment initiation

Other Outcomes (1)

• Disease-Free Survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Patients will receive standard of care surgery (no intervention prior to surgery)

Other: Standard of Care (SOC)

Capecitabine

EXPERIMENTAL

Patients will receive capecitabine prior to surgery

Drug: Capecitabine

Interventions

Capecitabine DRUG

Patients will receive fixed-dose capecitabine prior to surgery

Capecitabine

Standard of Care (SOC) OTHER

Standard of care (no intervention until surgery)

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated, histologically confirmed non-HPV related HNSCC and radiologically or histologically confirmed stage I or IVA (AJCC 8th edition).
• No evidence of distant metastatic disease.
• Able to undergo protocol therapy, including necessary imaging and surgery.
• If female: may participate if not actively pregnancy nor breastfeeding.
• If male: must agree to refrain from donating sperm and must either be abstinent or agree to use contraception.
• Performance status (ECOG) of 0, 1 or 2.

You may not qualify if:

• History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority.
• Active infection requiring systemic therapy.
• Previous allogenic tissue/solid organ transplant.
• Known severe hypersensitivity (≥ Grade 3) to capecitabine, its active substance and/or any of its excipients.
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
• Known DYPD mutation.
• Known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
• Received prior systemic anticancer therapy including investigational agents for the current malignancy prior to allocation.
• Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
• Known additional malignancy that is progressing or requires active treatment within the past (5 years), excluding basal cell carcinoma or cutaneous squamous cell carcinoma.

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Lady Davis Institute: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Laryngeal Neoplasms

Interventions

Capecitabine; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marco Mascarella, MD, MSc, PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Mascarella, Assistant Professor of Otolaryngology, MD, MSc, PhD

CONTACT

514-934-1934; marco.mascarella@mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: November 28, 2025

Record last verified: 2025-11